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<p>ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.</p>
<p>ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:</p>
<ul>
<li>the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;</li>
<li>the establishment of stability of the IVD reagent in use after the first opening of the primary container;</li>
<li>the monitoring of stability of IVD reagents already placed on the market;</li>
<li>the verification of stability specifications after modifications of the IVD reagent that might affect stability.</li>
</ul>
Reģistrācijas numurs (WIID)
89155
Darbības sfēra
<p>ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.</p>
<p>ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:</p>
<ul>
<li>the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;</li>
<li>the establishment of stability of the IVD reagent in use after the first opening of the primary container;</li>
<li>the monitoring of stability of IVD reagents already placed on the market;</li>
<li>the verification of stability specifications after modifications of the IVD reagent that might affect stability.</li>
</ul>
